Trials / Not Yet Recruiting
Not Yet RecruitingNCT06093165
RE-irradiation of Diffuse MIdline Glioma paTients
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 59 (estimated)
- Sponsor
- Rigshospitalet, Denmark · Academic / Other
- Sex
- All
- Age
- 12 Months – 21 Years
- Healthy volunteers
- Not accepted
Summary
The REMIT (RE-irradiation of diffuse MIdline glioma paTients) study evaluates safety and the palliative efficacy of re-irradiation of patients with diffuse midline glioma (DMG). The study will introduce a standard re-irradiation treatment schedule for DMG patients who have progressed following primary treatment.
Detailed description
REMIT is a non-randomized, prospective, investigator-initiated, phase II, multi-centre observational study with two inclusion groups, arm A and B. Arm A and B will be offered the same treatment. Patients treated with primary radiotherapy 54Gy/30 fractions, either enrolled in the BIOMEDE 2.0 protocol or not, will be included in Arm A. DMG patients treated with any other total dose and fractionation than 54Gy/30F will be included in Arm B. The re-RT and follow up will be the same in both arms. As treatment 20Gy/10 fractions is given as first time re-irradiation with extended follow up on toxicity, performance status and quality of life.
Conditions
- Diffuse Midline Glioma, H3 K27M-Mutant
- Diffuse Intrinsic Pontine Glioma
- Diffuse Glioma
- Pontine Tumors
- Thalamic Tumor
- Brain Tumor, Pediatric
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | Re-irradiation | 20Gy on 10 fractions |
Timeline
- Start date
- 2023-10-01
- Primary completion
- 2029-11-01
- Completion
- 2029-11-01
- First posted
- 2023-10-23
- Last updated
- 2023-10-23
Source: ClinicalTrials.gov record NCT06093165. Inclusion in this directory is not an endorsement.